冻干甲肝减毒活疫苗安全性及免疫原性观察

目的评价国产冻干甲肝减毒活疫苗的安全性和免疫原性。方法选择部分18~24月龄健康儿童接种1剂甲肝减毒活疫苗,使用统一的"疫苗接种日记卡"观察记录疫苗接种后副反应,于免后28 d采集血清检测抗-HAVIgG。结果共接种18~24月龄健康儿童354人,14 d内副反应发生率10.73%,发热反应发生率为7.06%,未观察到严重异常反应;检测有效血清标本333份,免后28 d抗-HAV阳性率为92.79%,抗-HAV GMT为14.60 mIU/ml。结论国产冻干甲肝减毒活疫苗具有良好的安全性和免疫原性。

Observation on Safety and Immunogenicity of Freeze - dried Live Attenuated Hepatitis A Vaccine

Objective To evaluate the safety and immunogenicity of domestic lyophilized live attenuated hepatitis A(HA) vaccine. Methods Some healthy children at 18～24 months of age were selected to inoculate with a single dose of freeze-dried live attenuated HA vaccine,and the adverse reactions after inoculation were monitored and recorded using a uniform "vaccination diary card".The serum samples were collected 28 days poat-vaccination for detection of IgG anti-HAV. Results A total of 354 healthy children aged 18 to 24 months were inoculated with freeze-dried live attenuated HA vaccine.The incidence rates of adverse reactions and febrile response within 14 days were 10.73% and 7.06%,respectively.No severe abnormal responses were observed.333 serum samples were detected effectively.28 days after vaccination,the positive rate of anti-HAV was 92.79% and GMT of anti-HAV was 14.60 mIU/ml. Conclusions Domestic freeze-dried live attenuated HA vaccine shows a good safety and immunogenicity profile.